Study to Assess the Safety of Nivolumab in the Treatment of Metastatic Melanoma, Lung Cancer, Renal Cancer, Squamous Cell Carcinoma of the Head and Neck, and Chronic Hodgkin Lymphoma in Adults in Mexico

NCT ID: NCT03161613

Last Updated: 2022-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-17

Study Completion Date

2019-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a post-marketing study of patients who started nivolumab as first- or second-line therapy for metastatic melanoma or as second-line therapy for metastatic squamous non-small cell lung cancer (SqNSCLC) , metastatic non-SqNSCLC, metastatic renal cell carcimona (RCC), or recurrent or metastatic squamous cell carcinoma of the head and neck cancer (SCCHN), or third-line therapy for classical Hodgkin lymphoma (cHL) in Mexico.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Indications Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cancer patients in Mexico

lung cancer, melanoma cancer, renal cancer, Squamous Cell Carcinoma of the Head and Neck, and chronic Hodgkin Lymphoma patients in Mexico who have failed at least one treatment before being treated with nivolumab

Non-Interventional

Intervention Type OTHER

Non-Interventional

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Non-Interventional

Non-Interventional

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Male and female adult patients \> 18 years of age who have a confirmed diagnosis of advanced or metastatic melanoma and is indicated for the treatment of advanced (unresectable or metastatic) melanoma; metastatic NSCLC; metastatic RCC; recurrent or metastatic SCCHN; or cHL in Mexico
2. Male and female adult patients \> 18 years of age who completed the following lines of therapy: first-line platinum treatment for metastatic SqNSCLC or non-SqNSCLC; 1 first-line treatment for metastatic RCC; first-line platinum therapy for SCCHN; or bretuximab vedontin for the treatment of cHL
3. Patients who present with brain metastases are allowed, if asymptomatic, do not have edema, and are not receiving corticosteroids or radiation
4. Patients have received at least 1 dose of nivolumab
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Local Institution

Mexico City, Mexico City, Mexico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Mexico

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CA209-869

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.